ClearanceBrief
510(k) K081412 ยท FRN Pump, Infusion

PLUM A+ HYPERBARIC INFUSION SYSTEM WITH HOSPIRA MEDNET SOFTWARE

ApplicantHospira, Inc., Lake Forest IL, US
DecisionSubstantially Equivalent, Dec 17, 2008
ReceivedMay 20, 2008
TypeTraditional
FDA recordOpen on fda.gov

Recalls that name K081412

DateFirm and productCodeLinked 510(k)
Sep 6, 2016Hospira Inc.
Plum A+ Hyperbaric Infusion Pump. List Number 11005. The Plum A+ Infusion Systems are a multi-purpose family of devices that provides precise delivery of multiple therapies across the general spectr
Terminated
FRNNone listed
Sep 6, 2016Hospira Inc.
Plum A+ Infusion Pump. List Number 11971. The Plum A+ Infusion Systems are a multi-purpose family of devices that provides precise delivery of multiple therapies across the general spectrum of clinic
Terminated
FRNNone listed
Sep 6, 2016Hospira Inc.
Plum A+ Infusion Pump. List Number 11973. The Plum A+ Infusion Systems are a multi-purpose family of devices that provides precise delivery of multiple therapies across the general spectrum of clinic
Terminated
FRNNone listed
Sep 6, 2016Hospira Inc.
Plum A+3 Infusion Pump. List Number 12391. The Plum A+ Infusion Systems are a multi-purpose family of devices that provides precise delivery of multiple therapies across the general spectrum of clini
Terminated
FRNNone listed
Sep 6, 2016Hospira Inc.
Plum A+ Infusion Pump with Hospira MedNet Software. List Number 20679. The Plum A+ Infusion Systems are a multi-purpose family of devices that provides precise delivery of multiple therapies across t
Terminated
FRNNone listed
Sep 6, 2016Hospira Inc.
Plum A+ Infusion Pump with Hospira MedNet Software. List Number 20792. The Plum A+ Infusion Systems are a multi-purpose family of devices that provides precise delivery of multiple therapies across t
Terminated
FRNNone listed
Sep 6, 2016Hospira Inc.
Plum A+3 Infusion Pump System. List Number 12348. The Plum A+ Infusion Systems are a multi-purpose family of devices that provides precise delivery of multiple therapies across the general spectrum o
Terminated
FRNNone listed
Sep 6, 2016Hospira Inc.
Plum A+3 Infusion Pump. List Number 12618. The Plum A+ Infusion Systems are a multi-purpose family of devices that provides precise delivery of multiple therapies across the general spectrum of clini
Terminated
FRNNone listed
Sep 6, 2016Hospira Inc.
Plum A+3 Infusion Pump with Hospira MedNet Software. List Number 20678. The Plum A+ Infusion Systems are a multi-purpose family of devices that provides precise delivery of multiple therapies across
Terminated
FRNNone listed
Feb 23, 2015Hospira Inc.
The Plum A+ Infusion System is designed to meet the fluid delivery requirements of today's evolving healthcare environments. It is a cassette based multi-function infusion system. The Plum A+ allows t
Terminated
FRNNone listed
Nov 14, 2013Hospira Inc.
Plum A+ Hyperbaric Infusion Pump; List Number 11005; Labeled in part: PLUM A+ HYPERBARIC; Product Usage: The Plum A+ Infusion Systems are a multipurpose family of devices that provides precise d
Terminated
FRNNone listed
Nov 14, 2013Hospira Inc.
The Plum A+ Hyperbaric Infusion System is a cassette based multifunction infusion system that allows two lines in and one line out and can be used for standard, piggyback, or concurrent delivery. The
Terminated
FRNNone listed
Dec 31, 2012Hospira Inc.
Plum A+ Hyperbaric Single Channel Infusion Pumps; Hospira, Inc., Lake Forest, IL 60045; list number 11005 Product Usage: The Plum A+ Hyperbaric Infusion System is exclusively designed for hyperbaric t
Terminated
FRNNone listed
Dec 7, 2012Hospira Inc.
Plum A+ Hyperbaric Single Channel Infusion Pumps with Hospira MedNet Software and a Connectivity Engine peripheral module that provides wired Ethernet and wireless local networking, allowing the MedNe
Terminated
FRNNone listed
Oct 4, 2011Hospira Inc.
Plum A+ Hyperbaric Single Channel Infusion Pumps; Hospira, Inc., Lake Forest, IL 60045; list 11005 Product Usage: The Plum A+ Hyperbaric Infusion System is exclusively designed for hyperbaric ther
Terminated
FRNNone listed
Sep 29, 2011Hospira Inc.
Plum A+ Hyperbaric Single Channel Infusion Pumps; Hospira, Inc., Lake Forest, IL 60045; list 11005. Hospira has received reports of incorrect seating of the regulator closer on the Plum A+ Infusion P
Terminated
FRNNone listed
Mar 14, 2011Hospira Inc.
Plum A+ Hyperbaric Single Channel Infusion Pumps; Hospira, Inc., Lake Forest, IL 60045; list 11005 The Plum A+ Hyperbaric Infusion System is exclusively designed for hyperbaric therapy in monospace a
Terminated
FRNNone listed

Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.